510(k) · Cleared

Cleared

Synthes Reconstructive Plates 'Y' Plates

K792291510(k) TraditionalCleared Dec 6, 197923-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (Usa) · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Cleared on Dec 6, 1979 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 80 later devices descend from it.

Decided: Dec 6, 1979
Review: 23 days
Class: Class II
Product code: KTW
Recalls: None
Predicates: 0

80 later devices descend from it, 7 citing it directly.

This deviceK792291 Synthes Reconstructive Plates 'Y' PlatesSynthes (Usa) · 1979
Descendant · cites it directly · 61 of its ownK960533 K3 Bone Screw SystemKinetikos Medical, Inc. · 1996
Descendant · cites it directly · 41 of its ownK960537 K2 Bone Screw SystemKinetikos Medical, Inc. · 1996
Descendant · 2 generations on · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
Descendant · 3 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
Descendant · 4 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

1996high 9 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 80 · See all

K960533K3 Bone Screw SystemKinetikos Medical, Inc. · 1996 · cites it directly61descendants
K960537K2 Bone Screw SystemKinetikos Medical, Inc. · 1996 · cites it directly41descendants
K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · 2 generations on39descendants
K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 3 generations on36descendants
K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 4 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K792291	Synthes Reconstructive Plates 'Y' Plates	Synthes (Usa)	1979	—
+1	K960533	K3 Bone Screw System	Kinetikos Medical, Inc.	1996	—
+1	K960537	K2 Bone Screw System	Kinetikos Medical, Inc.	1996	—
+2	K120493	Mini Cannulated Headed and Headless Screw Set	Instratek, Inc.	2012	1
+3	K123890	Acumed Cannulated Screw System	Acumed, LLC	2013	2
+4	K190586	Monster® Screw System	Paragon 28, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	2	0
1998	1	0
1999	1	0
2002	1	0
2003	1	0
2004	1	0
2005	4	0
2006	1	0
2007	2	0
2012	1	0
2013	3	0
2015	2	0
2016	1	0
2017	6	0
2018	3	0
2019	8	0
2020	6	0
2021	2	0
2022	9	0
2023	9	0
2024	4	0
2025	5	0
2026	5	0

FIG. 1 — Lineage of K792291, 1979–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (80)

See all 80

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K960533	K3 Bone Screw System	Kinetikos Medical, Inc.	1996	61
K960537	K2 Bone Screw System	Kinetikos Medical, Inc.	1996	41
K972219	Orthopedic Plate System	Ferguson Medical	1997	8
K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	4
K990019	DRG Medium Screw System	Dolphin Medical Technologies, Inc.	1999	0
K973810	DRG Large Screw System	Dolphin Medical Technologies, Inc.	1998	0
K972217	Orthopedic Screw System	Ferguson Medical	1997	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K960533 (Kinetikos Medical, Inc., 1996) has gone furthest, with 61 descendants of its own.

How does its category compare?

All KTW devices

KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTW

1in 2019

2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTW

Too few KTW 510(k)s in any year since 2007 to give a median.

Recalls per year · KTW

57in 2010

2007high 57 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTW

96in 2025

2007high 123 (2024) · low 2 (2009)2025

MAUDE reports naming product code KTW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	3
2008	2	—	0	10
2009	0	—	0	2
2010	0	—	57	26
2011	0	—	0	21
2012	1	—	0	70
2013	0	—	0	70
2014	0	—	0	62
2015	0	—	0	26
2016	1	—	0	41
2017	2	—	0	27
2018	0	—	0	24
2019	1	—	0	11
2020	0	—	0	60
2021	0	—	0	25
2022	0	—	0	50
2023	0	—	0	30
2024	0	—	0	123
2025	0	—	0	96
2026	0	—	0	—

https://510kreport.com/device/K792291 · printed Nov 6, 2026

Cite this page

510(k) Report. “K792291: Synthes Reconstructive Plates 'Y' Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K792291

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026